Clinical Trial Manager
Core
End-to-end operational oversight and delivery of clinical trials at the country level, ensuring adherence to timelines, budget, and quality standards while coordinating with internal and external stakeholders.
Role type
Senior Clinical Trial Manager (Country Level)
Builds
Clinical trial studies for innovative medicines
Domain
Life Sciences / Clinical Research
Required skills
GCP and ICH Guidelines knowledge, clinical research process expertise, risk management, stakeholder coordination, regulatory submission management, data management (CTMS/eDC/eTMF), vendor management, project planning
Preferred skills
Therapeutic area expertise, mentoring capabilities, subject matter expert status
Technologies
Microsoft Suite, CTMS, eDC, eTMF
Responsibilities
Implement local country and site feasibility processes, plan and execute study start-up timelines, manage patient recruitment strategies and risk mitigation, lead problem-solving and issue resolution, ensure data completeness in CTMS and eTMF, validate study materials, coordinate database locks and query follow-up, ensure inspection readiness, manage CAPA implementation, coordinate study team meetings, support regulatory submissions to Health Authorities and Ethics Committees, manage site relationships and closure activities.
Seniority
Senior, hands-on IC